3D Printing for Special Patient Populations
Dimitrios G Fatouros, Professor in Pharmaceutics, Department of Pharmacy, Aristotle University of Thessaloniki
Additive manufacturing (AM) technologies have revolutionised how healthcare provision is envisioned. The rapid evolution of these technologies has already created a momentum in the effort to address unmet personalised needs especially those belonging to sensitive subgroup populations (e.g., paediatric, geriatric, visually impaired, veterinary).
1. In your view, how does the adoption of additive manufacturing in healthcare specifically differ when addressing the needs of sensitive subgroups such as paediatric or geriatric populations compared to the general patient population?
Adoption increases when personalisation translates into visible clinical benefit and simpler use. In pediatrics, adjustable dosages (e.g., mini-tablets, ODTs, films) and friendly form factors matter as much as device safety. In geriatrics, low-burden swallowable or mucosal dosage forms and patient-specific surgical guides/implants shorten procedures and recovery. For visually impaired users, tactile cues and unambiguous workflows, on both packaging and device interfaces, are decisive. When solutions reduce caregiver effort and error risk, uptake follows.
2. What are the most significant design and material considerations when developing 3D-printed medical devices or implants for paediatric patients, given their rapid growth and developmental variability?
For dosage forms, it is essential to prioritise age-appropriate excipients, tastemasking, and small units (e.g., ≤3–4 mm mini-tablets, printable ODTs/films) that permit fine dose titration without tablet splitting. For devices, compliant medical-grade polymers (silicone/TPU), rounded geometries, and designs that accommodate growth, or easy refitting should be preferred. Across both, durability, validated sterilisation (or aseptic compounding, where relevant), and biocompatibility is non-negotiable.
3. From a clinical standpoint, what challenges arise when integrating 3D-printed assistive devices for visually impaired patients, and how do you see these challenges being addressed in the near future?
Key challenges include ergonomics, durability, and adaptability to different levels of visual impairment. Dosage forms benefit from high-contrast labeling, Braille/tactile markers, distinct unit shapes, and packaging that “clicks” or audibly confirms a correct count. Devices should provide tactile or auditory confirmation of correct positioning. Early co-design sessions with end-users will significantly prevent downstream usability failures.
4. To what extent can additive manufacturing reduce procedural invasiveness or recovery time in geriatric patients, and what clinical evidence do you believe still needs to be established?
AM enables patient-specific guides and implants that reduce operative time and incision size. On the pharmaceutical side, print-on-demand ODTs, buccal films, and low-effort multiparticulates can ease administration in dysphagia and frailty. Personalized polypills or synchronised release profiles can simplify complex regimens, improving adherence and therapeutic outcomes. However, robust clinical evidence from large-scale and longitudinal trials is still needed to validate the long-term safety and effectiveness of such approaches.
5. How does regulatory approval and standardisation of 3D-printed healthcare products differ when the target demographic is a sensitive population, and what frameworks do you see evolving to address this?
Two pillars are considered important; controlled processes and traceability. For dosage forms, that means content uniformity, dissolution/release verification and stability aligned with established pharmacopeial methods. For devices, validated print parameters, material lot control, and a digital thread linking model to part are essential. Aligning early with ISO/ASTM AM standards and a medical QMS framework will help streamline review, while human factors and usability evidence is vital for sensitive populations. International harmonisation of standards will likely become essential as adoption grows.
6. In terms of cost-effectiveness, how do you balance the economic viability of 3D printing solutions for niche patient subgroups with the broader scalability demands of healthcare systems?
Economic evaluation must extend beyond the printer to the care pathway. We should account for operating room minutes saved, avoided revisions, reduced inventory waste, and shorter hospital stays with respect to 3D printed devices. When a custom device consistently shortens procedures or prevents re-intervention, the cost case is generally favorable at scale.
7. What role do patient-specific anatomical data, such as pediatric imaging scans or geriatric bone density profiles, play in ensuring the functional accuracy of 3D-printed implants and prosthetics?
Patient-specific imaging (CT, MRI) and biometric data are central to ensuring the precision and functionality of 3D-printed implants; data quality governs clinical safety. In pediatrics, models must anticipate future growth, while in geriatrics, considerations such as osteoporosis, reduced tissue elasticity, and comorbidities must guide design. High-fidelity segmentation, verified landmarks, realistic tolerances, and controls for manufacturing drift are essential. Throughout the digital thread, privacy protection and access control must also be explicit.
8. Looking at the veterinary field, where 3D printing is gaining traction, what translational lessons can be drawn for human healthcare applications in vulnerable populations?
Veterinary applications often benefit from less restrictive regulatory frameworks, enabling faster adoption of AM solutions. Lessons include practical experience in rapid prototyping, cost-efficient customisation, and iterative design. These insights are valuable for mechanical and use-pattern de-risking. Translation to humans, however, must respect distinct regulatory, ethical, and follow-up requirements.
9. How do you envision additive manufacturing influencing the future of drug delivery mechanisms, particularly in tailoring dosage forms for children or elderly patients who face swallowing or compliance difficulties?
AM holds transformative potential in pharmaceutical sciences. It enables personalized drug dosage forms tailored to age, weight, or pharmacokinetics. For children and elderly patients, this means chewable tablets, fast-dissolving films, or multiparticulate systems that address swallowing difficulties and compliance issues. The main hurdles remain dose uniformity, stability, sterilisation compatibility, and GMP-ready workflows. With maturing hospital-pharmacy capabilities, distributed manufacturing is becoming more feasible.
10. What are the bioethical concerns you see emerging around the use of patient-specific 3D-printed solutions, especially when dealing with vulnerable or dependent populations?
Ethical challenges include ensuring equitable access to highly individualised solutions, protecting sensitive imaging and biometric data, and avoiding over-personalization that could exclude patients with fewer resources. Patients should understand what is being personalized and on what data it rests. One-off or small-batch products may raise questions on recallability, comparability, and end-of-life management and these must be addressed at design time.
11. How important is interdisciplinary collaboration - between material scientists, clinicians, bioengineers, and patient advocacy groups - in ensuring that 3D printing technologies are inclusive for special populations?
No single discipline can get AM safely to a bedside. You need materials scientists, clinicians, imaging engineers, human-factors experts, and regulatory competence working under shared design controls. Rapid plan-print-test-refine cycles, with common metrics, are the most efficient route to reliable products.
12. Could you elaborate on the role of machine learning and simulation tools in optimising 3D-printed devices for unique patient anatomies, and how far these tools can reduce trial-and-error design in sensitive populations?
We should treat ML as an accelerator, not an autopilot. They’re terrific for narrowing the search space by predicting printability, tuning lattice structures, and spotting defects in QA. Their value depends on rigorous ground-truth data from bench, preclinical, and clinical studies.
13. In your experience, what infrastructural or logistical barriers prevent healthcare providers from fully embracing 3D printing for customised solutions in rural or resource-limited settings, especially for vulnerable groups?
Typical constraints that apply to both domains include power, sterility, maintenance, and training. A hub-and-spoke approach can centralise complex fabrication while local sites may dispense validated, pre-qualified dosage forms and manage fitting/follow-up for devices. Early focus on high-impact, lower-complexity items like guides; simple ODTs/films/mini-tablets can build sustainable capacity and democratise access for vulnerable groups in under-resourced settings.
14. Finally, as the field evolves, what future breakthroughs in additive manufacturing do you anticipate will have the greatest transformative effect on healthcare delivery for populations such as paediatric, geriatric, and visually impaired patients?
The most transformative breakthroughs are expected in:
• Bioprinting of tissues and organs, addressing transplant shortages.
• Smart materials capable of dynamic responses to biological stimuli.
• On-demand pharmaceutical printing within hospitals or even at community pharmacies.
These advances will fundamentally reshape healthcare delivery for pediatric, geriatric, and visually impaired patients by making medicine more adaptive, responsive, and truly personalized.
Author Bio
Dimitrios Fatouros is a Professor at Aristotle University of Thessaloniki School of Pharmacy. His areas of research expertise cover advanced drug delivery systems, nanomedicine and nanotechnology with special focus on additive manufacturing, mucosal delivery, poorly soluble drugs, in vitro digestion models and self-assembling peptides. He has co-authored over 220 peer research articles and book chapters and has filled nine national and international patents and patent applications. He is Deputy Editor in Chief of Journal of Drug Delivery Science and Technology (Elsevier) and member of the Editorial Boards of International Journal Pharmaceutics, International Journal Pharmaceutics X (Elsevier) and an Expert Member of the conect4children (c4c) Formulations Expert Group.
